Spain's Ministry of Health (Ministerio de Sanidad) published Order SND/1053/2026 in the Boletín Oficial del Estado on October 7, 2026, updating the reference pricing system for medicines funded by the National Health System (SNS) for 2026. The order takes effect on October 8, 2026, the day after publication, replacing the 2025 reference sets of Order SND/1118/2025.
Originator and generic pharmaceutical companies with NHS-reimbursed medicines, marketers of hospital presentations in the new sets, and Spanish distributors and community pharmacies must align their reimbursement prices to the 2026 reference prices in annexes 1 and 2 by October 8, 2026, or presentations priced above the reference price lose full NHS reimbursement, with the patient paying the difference unless the manufacturer cuts its price to the reference level. The update creates fifteen new pharmacy reference sets (F514 to F528) and eleven new hospital sets (P206 to P216), revises the reference prices of existing sets, and suppresses sets in annex 4 that no longer meet the requirements.
Which reference sets are new, revised or suppressed?
Annex 1 lists the reference sets for medicines dispensed in pharmacies on prescription, fixing the reference industrial price (PVL) and the reference VAT-inclusive retail price (PVP IVA) for each presentation; sets F514 to F528 are newly created. Annex 2 lists hospital-scope medicines and clinical-container presentations, with sets P206 to P216 newly created and no new clinical-container sets. Annex 4 sets out the suppressed sets that no longer meet the requirements, removing their prior reference-price grouping entirely.
The order also protects supply of essential medicines: for presentations the World Health Organization considers essential and that cannot be substituted by another funded medicine, the reference price is not revised, so their funding terms hold. Annex 8 lists presentations the Interministerial Medicines Prices Commission has exempted from the system.
Who must align their prices, and by when?
The update binds three groups by market exposure: originator and generic laboratories with NHS-reimbursed prescription medicines in the updated sets (among the operators visible in annex 1 are Cinfa, Kern Pharma, Normon, Stada, Teva, Sandoz, Viatris and Aurovitas, alongside originators such as GSK and Merck); marketers of hospital medicines and clinical-container presentations in the new sets P206 to P216; and the distributors and community pharmacies that dispense NHS-reimbursed medicines at the updated reference prices. The reference price is the maximum the SNS reimburses for a presentation in a set.
Each affected laboratory must therefore decide, for every presentation it sells, whether to cut its price to the new reference level or keep its price and accept the lower NHS reimbursement, with the patient paying the difference. A presentation in a suppressed set (annex 4) loses its previous reference-price grouping, so its reimbursement moves to whatever set the order assigns it to, or to general pricing if none applies.
What changed for hospital medicines and exemptions?
The eleven new hospital sets P206 to P216 in annex 2 extend reference pricing to additional hospital and clinical-container presentations, fixed under article 4.4 of Royal Decree 177/2014 where aggregated hospital spend data is available. Hospital marketers should re-check whether each presentation sits in a new set, a revised set or no set at all, and align their tender terms accordingly.
A reform introduced by Law 7/2025 of July 28, 2025 amended article 98 of the consolidated Medicines Act (Royal Legislative Decree 1/2015) and empowers the Interministerial Medicines Prices Commission, with the autonomous communities, to exempt specific medicines from the reference-price system or apply a coefficient that increases their reference price; for strategic medicines recognized by the AEMPS, it may also revise prices upward on motivated grounds. Laboratories with an exemption or coefficient should confirm their treatment in annex 8 before setting their price.
| Annex | What it contains | What to check |
|---|---|---|
| 1 | Pharmacy reference sets (F514 to F528 new) | Your presentation's set, PVL and PVP IVA reference |
| 2 | Hospital and clinical-container sets (P206 to P216 new) | Whether your hospital presentation moved sets |
| 4 | Suppressed sets | Whether your set lost its reference-price grouping |
| 8 | Exemptions granted by the Prices Commission | Whether your product is exempt |
What to do before October 8, 2026
- Check annexes 1 and 2 for every presentation you sell to the SNS: its set code, reference PVL and reference PVP IVA.
- Flag presentations that moved into a new set (F514 to F528, P206 to P216), a revised set, or a suppressed set in annex 4.
- Decide for each affected presentation whether to cut the price to the reference level or keep it and accept lower reimbursement with a patient co-payment.
- Update distribution agreements, pharmacy-system prices and hospital tender terms to the new reference prices.
- Review annexes 5, 7 and 8 for exclusions, new inclusions and exemptions that change your treatment.
- Note the appeal routes: a contentious-administrative appeal before the Audiencia Nacional within two months, or an optional reposicion before the Ministra de Sanidad within one month.
Obsidian's continuous, per-jurisdiction monitoring of the BOE surfaces a reference-price reset like this the moment it publishes, so market-access teams can reconcile their portfolio before the order takes effect.
Map every NHS-reimbursed presentation against the 2026 annexes, confirm the price-cut or co-payment decision for each, and brief the market-access and distribution teams before the appeal windows close. The reference-price regime stays in force until the Proyecto de Ley del Medicamento, expected in the first half of 2027, replaces it with a dynamic-pricing system.
